Prostate Cancer Clinical Trial
— PRIMUSOfficial title:
Prostate Cancer Immune Profiling Before, During and After HDR-brachytherapy in Local Relapsed Prostate Cancer (PRIMUS-study)
NCT number | NCT04247217 |
Other study ID # | PRIMUS |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 19, 2020 |
Est. completion date | December 23, 2021 |
Verified date | May 2022 |
Source | Maastricht Radiation Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Immunotherapy is currently revolutionizing the field in oncology. However, prostate cancer until now fails to respond to classical IO, like PD-1 and CTLA-4 inhibitors. Radiotherapy (RT) delivered to the primary tumor impacts both tumor cells and surrounding stromal cells. Radiation damage to cancer cells exposes tumor-specific antigens leading to increased visibility to the immune system by improved priming and activation of cytotoxic T cells. RT-induced modulation of the tumor microenvironment may also facilitate the recruitment and infiltration of immune cells by increasing the expression or T-cell attracting chemokines and by increasing T-cell docking molecules on the endothelial cells like VCAM-1. The main-hypothesis is that HDR-brachytherapy will turn an immunologically "cold" (no T-cell infiltrations) prostate cancer into an immunologically "hot" (CD4 and CD8-cell infiltrations) tumor, creating leverage points for different forms of IO.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 23, 2021 |
Est. primary completion date | December 23, 2021 |
Accepts healthy volunteers | |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Local relapse of prostate cancer, who is candidate for a salvage HDR treatment: - Biochemical relapse (PSA increase) - Local relapse on imaging: PSMA scan, mp-MRI - Pathology proven relapse - Willing and able to comply with the study prescriptions. - 18 years or older - Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. Exclusion Criteria: - Not eligible for proposed (HDR brachytherapy) treatment: - Life expectancy < 10 years - Distant Metastasis - Recently TURP with big urethral defect - Not able to stop anticoagulants - Flow < 10 ml/sec • No compliance to study procedure |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastro | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht Radiation Oncology |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Expression of PD-(L)-1 receptor | Expression of PD-(L)-1 receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points. | up to 28 days | |
Secondary | Expression patterns of CXCL12 | Expression of CXCL12 receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points | up to 28 days | |
Secondary | Expression patterns of IL-23 | Expression of IL-23 receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points | up to 28 days | |
Secondary | Expression patterns of MDSC | Expression of MDSC receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points | up to 28 days | |
Secondary | Changes in T cell infiltration profiles | Changes in T cell infiltration profiles induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points | up to 28 days | |
Secondary | Changes in HLA class I-A expression on tumor cells | Changes in HLA class I-A expression on tumor cells induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points | up to 28 days | |
Secondary | Changes in HLA class I-B expression on tumor cells | Changes in HLA class I-B expression on tumor cells induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points | up to 28 days | |
Secondary | Changes in HLA class I-C expression on tumor cells | Changes in HLA class I-C expression on tumor cells induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points | up to 28 days |
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